NovoNordisk Gets CDSCO Panel Nod To Study anti-diabetic FDC Cagrilinitide,Semaglutide

Published On 2022-09-19 12:30 GMT | Update On 2022-09-19 12:30 GMT

New Delhi: Advising to submit the trial safety and efficacy data, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has given its nod to drug major Novo-Nordisk for conducting the phase III clinical trial of anti-diabetic fixed dose combination drug containing Cagrilinitide and Semaglutide.

This came after the drug maker Novo-Nordisk presented the proposed Phase IIIa trial protocol no. NN9838-4608, Version 03 dated 24Jun2022 (REDEFINE) for FDCs anti-diabetic drug Cagrilinitide plus Semaglutide before the committee.

The nod is subjected to condition that the firm should submit the trial safety and efficacy data to the committee for review and further initiation of the extension phase.

Cagrilintide is a long-acting amylin analogue intended for once-weekly treatment being developed by Novo Nordisk, as a subcutaneous formulation, for the treatment of obesity and non-alcoholic steatohepatitis.

Semaglutide is a glucagon-like peptide 1 (GLP-1) analog used to manage type 2 diabetes along with lifestyle changes, such as dietary restrictions and increased physical activity. GLP-1 is a physiological hormone that promotes glycemic control via several different mechanisms, including insulin secretion, slowing gastric emptying, and reducing postprandial glucagon secretion. The homeostasis of glucose is dependent on hormones such as insulin and amylin, which are secreted by the beta cells of the pancreas.

Also Read:NovoNordisk Gets CDSCO Panel Okay To Study Anti-Diabetic Drug Semaglutide

Semaglutide is 94% similar to human GLP-1. Analogs of this hormone such as semaglutide stimulate the synthesis of insulin by stimulating pancreatic islet cells and reducing glucagon secretion. They directly bind with selectivity to the GLP-1 receptor, causing various beneficial downstream effects that reduce blood glucose in a glucose-dependent fashion.

At recent SEC meeting for endocrinology and metabolism held on 9th September 2022,the expert panel reviewed the proposal presented by the drug marker Novo-Nordisk for the FDCs anti-diabetic drug Cagrilinitide plus Semaglutide Phase IIIa trial protocol no.NN9838-4608,Version 03 dated 24Jun2022 (REDEFINE)

After detailed deliberation, the committee recommended for grant of permission to conduct the trial with the condition that the firm should submit the trial safety and efficacy data to the committee for review and further initiation of the extension phase.

Also Read:CDSCO panel seeks justification for Pfizer Phase III CT of 20-Valent Pneumococcal Conjugate Vaccine

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Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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NovoNordisk Gets CDSCO Panel Nod To Study anti-diabetic FDC Cagrilinitide,Semaglutide

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